PTSM: Pharmaceutical Technology Sourcing and Management, Jul 9, 2008 - Pharmaceutical Technology

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PTSM: Pharmaceutical Technology Sourcing and Management, Jul 9, 2008
Global Feature
The Economics of Follow-on Biologics
By Patricia Van Arnum
A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved.
Information Technology and Software
Enterprise-Level Change Control
By Matthew Kopecky
Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.
Outsourcing
Toward a New Model for Contract Manufacturing
By Jim Miller
Global manufacturing excellence will be a game changer for CMOs that can achieve it.

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What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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